Final - EUA - Full PI - HCP Fact Sheet Pfizer-BioNTECH COVID-19 Vaccine

FACT SHEET FOR HEALTHCARE PROVIDERS ADMINISTERING VACCINE
(VACCINATION PROVIDERS)
EMERGENCY USE AUTHORIZATION (EUA) OF

THE PFIZER-BIONTECH COVID-19 VACCINE TO PREVENT CORONAVIRUS
DISEASE 2019 (COVID-19)
The U.S. Food and Drug Administration (FDA) has issued an Emergency Use
Authorization (EUA) to permit the emergency use of the unapproved product,
Pfizer-BioNTech COVID-19 Vaccine, for active immunization to prevent
COVID-19 in individuals 12 years of age and older and to provide a third dose
to individuals 12 years of age and older who have been determined to have
certain kinds of immunocompromise.
COMIRNATY (COVID-19 Vaccine, mRNA) is an FDA-approved COVID-19

vaccine made by Pfizer for BioNTech. It is approved as a 2-dose series for the
prevention of COVID-19 in individuals 16 years of age and older and is also
authorized for emergency use in individuals 12 through 15 years and to
provide a third dose to individuals 12 years of age and older who have been
determined to have certain kinds of immunocompromise.
The FDA-approved COMIRNATY (COVID-19 Vaccine, mRNA) and the

EUA-authorized Pfizer-BioNTech COVID-19 Vaccine have the same
formulation and can be used interchangeably to provide the COVID-19
vaccination series. 1
SUMMARY OF INSTRUCTIONS FOR COVID-19 VACCINATION PROVIDERS
Vaccination providers enrolled in the federal COVID-19 Vaccination Program must

report all vaccine administration errors, all serious adverse events, cases of
Multisystem Inflammatory Syndrome (MIS) in adults and children, and cases of
COVID-19 that result in hospitalization or death following administration of
Pfizer-BioNTech COVID-19 Vaccine. See “MANDATORY REQUIREMENTS FOR
PFIZER-BIONTECH COVID-19 VACCINE ADMINISTRATION UNDER
EMERGENCY USE AUTHORIZATION” for reporting requirements.
The Pfizer-BioNTech COVID-19 Vaccine is a suspension for intramuscular injection

administered as a series of two doses (0.3 mL each) 3 weeks apart.
A third dose of the Pfizer-BioNTech COVID-19 Vaccine (0.3 mL) administered at

least 28 days following the second dose of this vaccine is authorized for
administration to individuals at least 12 years of age who have undergone solid
1 The licensed vaccine has the same formulation as the EUA-authorized vaccine and the products
can be used interchangeably to provide the vaccination series without presenting any safety or
effectiveness concerns. The products are legally distinct with certain differences that do not impact
safety or effectiveness.
Revised: 23 August 2021 1

organ transplantation, or who are diagnosed with conditions that are considered to
have an equivalent level of immunocompromise.
See this Fact Sheet for instructions for preparation and administration. This Fact
Sheet may have been updated. For the most recent Fact Sheet, please see
www.cvdvaccine.com.
For information on clinical trials that are testing the use of the Pfizer-BioNTech
COVID-19 Vaccine for active immunization against COVID-19, please see
www.clinicaltrials.gov.
DESCRIPTION OF COVID-19
Coronavirus disease 2019 (COVID-19) is an infectious disease caused by the

novel coronavirus, SARS-CoV-2, that appeared in late 2019. It is predominantly a
respiratory illness that can affect other organs. People with COVID-19 have
reported a wide range of symptoms, ranging from mild symptoms to severe illness.
Symptoms may appear 2 to 14 days after exposure to the virus. Symptoms may
include: fever or chills; cough; shortness of breath; fatigue; muscle or body aches;
headache; new loss of taste or smell; sore throat; congestion or runny nose;
nausea or vomiting; diarrhea.
DOSAGE AND ADMINISTRATION
Storage and Handling
During storage, minimize exposure to room light, and avoid exposure to direct
sunlight and ultraviolet light.
Do not refreeze thawed vials.
Frozen Vials Prior to Use
Cartons of Pfizer-BioNTech COVID-19 Vaccine Multiple Dose Vials arrive in

thermal containers with dry ice. Once received, remove the vial cartons
immediately from the thermal container and preferably store in an ultra-low
temperature freezer between -90ºC to -60ºC (-130ºF to -76ºF) until the expiry date
printed on the label. This information in the package insert supersedes the storage
conditions printed on the vial cartons.
Cartons and vials of Pfizer-BioNTech COVID-19 Vaccine with an expiry date of

August 2021 through February 2022 printed on the label may remain in use for
3 months beyond the printed date as long as approved storage conditions
between -90ºC to -60ºC (-130ºF to -76ºF) have been maintained. Updated expiry
dates are shown below.

Printed Expiry Date Updated Expiry Date
August 2021  November 2021
September 2021  December 2021
October 2021  January 2022
November 2021  February 2022
December 2021  March 2022
January 2022  April 2022
February 2022  May 2022
If not stored between -90ºC to -60ºC (-130ºF to -76ºF), vials may be stored at -25°C
to -15°C (-13°F to 5°F) for up to 2 weeks. Vials must be kept frozen and protected
from light until ready to use. Vials stored at -25°C to -15°C (-13°F to 5°F) for up to
2 weeks may be returned one time to the recommended storage condition of -90ºC
to -60ºC (-130ºF to -76ºF). Total cumulative time the vials are stored at -25°C
to -15°C (-13°F to 5°F) should be tracked and should not exceed 2 weeks.
If an ultra-low temperature freezer is not available, the thermal container in which

the Pfizer-BioNTech COVID-19 Vaccine arrives may be used as temporary storage
when consistently re-filled to the top of the container with dry ice. Refer to the
re-icing guidelines packed in the original thermal container for instructions
regarding the use of the thermal container for temporary storage. The thermal
container maintains a temperature range of -90ºC to -60ºC (-130ºF to -76ºF).
Storage of the vials between -96°C to -60°C (-141°F to -76°F) is not considered an
excursion from the recommended storage condition.
Transportation of Frozen Vials
If local redistribution is needed and full cartons containing vials cannot be

transported at -90°C to -60°C (-130°F to -76°F), vials may be transported at -25°C
to -15°C (-13°F to 5°F). Any hours used for transport at -25°C to -15°C (-13°F to
5°F) count against the 2-week limit for storage at -25°C to -15°C (-13°F to 5°F).
Frozen vials transported at -25°C to -15°C (-13°F to 5°F) may be returned one time
to the recommended storage condition of -90ºC to -60ºC (-130ºF to -76ºF).
Thawed Vials Before Dilution
Thawed Under Refrigeration

Thaw and then store undiluted vials in the refrigerator [2ºC to 8ºC (35ºF to 46ºF)]
for up to 1 month. A carton of 25 vials or 195 vials may take up to 2 or 3 hours,
respectively, to thaw in the refrigerator, whereas a fewer number of vials will thaw
in less time.
Thawed at Room Temperature

For immediate use, thaw undiluted vials at room temperature [up to 25ºC (77ºF)] for
30 minutes. Thawed vials can be handled in room light conditions. Vials must reach
room temperature before dilution.

Undiluted vials may be stored at room temperature for no more than 2 hours.
Transportation of Thawed Vials
Available data support transportation of one or more thawed vials at 2°C to 8°C
(35°F to 46°F) for up to 12 hours.
Vials After Dilution
• After dilution, store vials between 2°C to 25°C (35°F to 77°F) and use within
6 hours from the time of dilution.
• During storage, minimize exposure to room light, and avoid exposure to
direct sunlight and ultraviolet light.
• Any vaccine remaining in vials must be discarded after 6 hours.
• Do not refreeze.
Dosing and Schedule
The Pfizer-BioNTech COVID-19 Vaccine is administered intramuscularly as a

series of two doses (0.3 mL each) 3 weeks apart.
The FDA-approved COMIRNATY (COVID-19 Vaccine, mRNA) and the

EUA-authorized Pfizer-BioNTech COVID-19 Vaccine have the same formulation
and can be used interchangeably to provide the COVID-19 vaccination series. 2
There are no data available on the interchangeability of the Pfizer-BioNTech

COVID-19 Vaccine or COMIRNATY (COVID-19 Vaccine, mRNA) with other
COVID-19 vaccines to complete the vaccination series.
A third dose of the Pfizer-BioNTech COVID-19 vaccine (0.3 mL) administered at

least 28 days following the second dose of this vaccine is authorized for
administration to individuals at least 12 years of age who have undergone solid
organ transplantation, or who are diagnosed with conditions that are considered to
have an equivalent level of immunocompromise.
Dose Preparation
Prior to Dilution
• The Pfizer-BioNTech COVID-19 Vaccine Multiple Dose Vial contains a
volume of 0.45 mL, supplied as a frozen suspension that does not contain
preservative. Each vial must be thawed and diluted prior to administration.
• Vials may be thawed in the refrigerator [2ºC to 8ºC (35ºF to 46ºF)] or at room
temperature [up to 25ºC (77ºF)] (see Storage and Handling).

• Refer to thawing instructions in the panels below.
Dilution
Dilute the vial contents using 1.8 mL of 0.9% Sodium Chloride Injection, USP (not
provided) to form the Pfizer-BioNTech COVID-19 Vaccine. ONLY use 0.9% Sodium
Chloride Injection, USP as the diluent. This diluent is not packaged with the vaccine
and must be sourced separately. Do not use bacteriostatic 0.9% Sodium Chloride
Injection or any other diluent. Do not add more than 1.8 mL of diluent.
After dilution, one vial contains 6 doses of 0.3 mL. Vial labels and cartons may
state that after dilution, a vial contains 5 doses of 0.3 mL. The information in this
Fact Sheet regarding the number of doses per vial after dilution supersedes the
number of doses stated on vial labels and cartons.
• Refer to dilution and dose preparation instructions in the panels below.
THAWING PRIOR TO DILUTION

• Thaw vial(s) of Pfizer-BioNTech
COVID-19 Vaccine before use either
by:
o Allowing vial(s) to thaw in the
refrigerator [2ºC to 8ºC (35ºF to
46ºF)]. A carton of vials may take up
to 3 hours to thaw, and thawed vials
can be stored in the refrigerator for
up to 1 month.
o Allowing vial(s) to sit at room
temperature [up to 25ºC (77ºF)] for
30 minutes.
• Using either thawing method, vials
must reach room temperature before
dilution and must be diluted within
2 hours.
• Before dilution invert vaccine vial

gently 10 times.
• Do not shake.
• Inspect the liquid in the vial prior to
dilution. The liquid is a white to off-
white suspension and may contain
white to off-white opaque amorphous
particles.
• Do not use if liquid is discolored or if
other particles are observed.

DILUTION
• Obtain sterile 0.9% Sodium Chloride

Injection, USP. Use only this as the
diluent.
• Using aseptic technique, withdraw
1.8 mL of diluent into a transfer syringe
(21-gauge or narrower needle).
• Cleanse the vaccine vial stopper with a
single-use antiseptic swab.
• Add 1.8 mL of 0.9% Sodium Chloride
Injection, USP into the vaccine vial.
• Equalize vial pressure before removing

the needle from the vial by withdrawing
1.8 mL air into the empty diluent
syringe.
• Gently invert the vial containing the

Pfizer-BioNTech COVID-19 Vaccine
10 times to mix.
• Do not shake.
• Inspect the vaccine in the vial.
• The vaccine will be an off-white
suspension. Do not use if vaccine is
discolored or contains particulate
matter.

• Record the date and time of dilution on
the Pfizer-BioNTech COVID-19
Vaccine vial label.
• Store between 2°C to 25°C (35°F to
77°F).
• Discard any unused vaccine 6 hours
after dilution.
PREPARATION OF INDIVIDUAL 0.3 mL DOSES OF PFIZER-BIONTECH

COVID-19 VACCINE
• Using aseptic technique, cleanse the
vial stopper with a single-use antiseptic
swab, and withdraw 0.3 mL of the
preferentially using a low dead-volume
syringe and/or needle.
• Each dose must contain 0.3 mL of
vaccine.
• If the amount of vaccine remaining in
the vial cannot provide a full dose of
0.3 mL, discard the vial and any
excess volume.
• Administer immediately.
Administration
Visually inspect each dose in the dosing syringe prior to administration. The
vaccine will be an off-white suspension. During the visual inspection,
• verify the final dosing volume of 0.3 mL.
• confirm there are no particulates and that no discoloration is observed.
• do not administer if vaccine is discolored or contains particulate matter.
Administer the Pfizer-BioNTech COVID-19 Vaccine intramuscularly.
After dilution, vials of Pfizer-BioNTech COVID-19 Vaccine contain six doses of

0.3 mL of vaccine. Low dead-volume syringes and/or needles can be used to
extract six doses from a single vial. If standard syringes and needles are used,
there may not be sufficient volume to extract a sixth dose from a single vial.
Irrespective of the type of syringe and needle:

• Each dose must contain 0.3 mL of vaccine.
• If the amount of vaccine remaining in the vial cannot provide a full dose of
0.3 mL, discard the vial and content.
• Do not pool excess vaccine from multiple vials.
Contraindications
Do not administer Pfizer-BioNTech COVID-19 Vaccine to individuals with known

history of a severe allergic reaction (e.g., anaphylaxis) to any component of the
Pfizer-BioNTech COVID-19 Vaccine (see Full EUA Prescribing Information).
Warnings
Management of Acute Allergic Reactions
Appropriate medical treatment used to manage immediate allergic reactions must

be immediately available in the event an acute anaphylactic reaction occurs
following administration of Pfizer-BioNTech COVID-19 Vaccine.
Monitor Pfizer-BioNTech COVID-19 Vaccine recipients for the occurrence of

immediate adverse reactions according to the Centers for Disease Control and
Prevention (CDC) guidelines (https://www.cdc.gov/vaccines/covid-19/clinical-
considerations/managing-anaphylaxis.html).
Myocarditis and Pericarditis
Postmarketing data demonstrate increased risks of myocarditis and pericarditis,

particularly within 7 days following the second dose. The observed risk is higher
among males under 40 years of age than among females and older males. The
observed risk is highest in males 12 through 17 years of age. Although some
cases required intensive care support, available data from short-term follow-up
suggest that most individuals have had resolution of symptoms with conservative
management. Information is not yet available about potential long-term sequelae.
The CDC has published considerations related to myocarditis and pericarditis
after vaccination, including for vaccination of individuals with a history of
myocarditis or pericarditis (https://www.cdc.gov/vaccines/covid-19/clinical-
considerations/myocarditis.html).
Syncope
Syncope (fainting) may occur in association with administration of injectable

vaccines, in particular in adolescents. Procedures should be in place to avoid injury
from fainting.

Altered Immunocompetence
Immunocompromised persons, including individuals receiving immunosuppressant

therapy, may have a diminished immune response to the Pfizer-BioNTech
COVID-19 Vaccine.
Limitation of Effectiveness
Pfizer-BioNTech COVID-19 Vaccine may not protect all vaccine recipients.
Adverse Reactions
Adverse Reactions in Clinical Trials

Adverse reactions following the Pfizer-BioNTech COVID-19 Vaccine that have
been reported in clinical trials include injection site pain, fatigue, headache, muscle
pain, chills, joint pain, fever, injection site swelling, injection site redness, nausea,
malaise, and lymphadenopathy (see Full EUA Prescribing Information).
Adverse Reactions in Post Authorization Experience

Severe allergic reactions, including anaphylaxis, and other hypersensitivity
reactions (e.g., rash, pruritus, urticaria, angioedema), diarrhea, vomiting, and pain in
extremity (arm) have been reported following administration of the Pfizer-BioNTech
COVID-19 Vaccine outside of clinical trials.
Myocarditis and pericarditis have been reported following administration of the

Pfizer-BioNTech COVID-19 Vaccine outside of clinical trials.
Additional adverse reactions, some of which may be serious, may become

apparent with more widespread use of the Pfizer-BioNTech COVID-19 Vaccine.
Use with Other Vaccines
There is no information on the co-administration of the Pfizer-BioNTech COVID-19

Vaccine with other vaccines.
INFORMATION TO PROVIDE TO VACCINE RECIPIENTS/CAREGIVERS
As the vaccination provider, you must communicate to the recipient or their

caregiver, information consistent with the “Vaccine Information Fact Sheet for
Recipients and Caregivers” (and provide a copy or direct the individual to the
website www.cvdvaccine.com to obtain the Vaccine Information Fact Sheet) prior to
the individual receiving each dose of Pfizer-BioNTech COVID-19 Vaccine,
including:
• FDA has authorized the emergency use of the Pfizer-BioNTech COVID-19
Vaccine, which is not an FDA-approved vaccine.
• The recipient or their caregiver has the option to accept or refuse
Pfizer-BioNTech COVID-19 Vaccine.

• The significant known and potential risks and benefits of Pfizer-BioNTech
COVID-19 Vaccine, and the extent to which such risks and benefits are
unknown.
• Information about available alternative vaccines and the risks and benefits of
those alternatives.
For information on clinical trials that are testing the use of the Pfizer-BioNTech
COVID-19 Vaccine to prevent COVID-19, please see www.clinicaltrials.gov.
Provide a vaccination card to the recipient or their caregiver with the date when the
recipient needs to return for the second dose of Pfizer-BioNTech COVID-19
Vaccine.
Provide the v-safe information sheet to vaccine recipients/caregivers and

encourage vaccine recipients to participate in v-safe. V-safe is a new voluntary
smartphone-based tool that uses text messaging and web surveys to check in with
people who have been vaccinated to identify potential side effects after COVID-19
vaccination. V-safe asks questions that help CDC monitor the safety of COVID-19
vaccines. V-safe also provides second-dose reminders if needed and live
telephone follow-up by CDC if participants report a significant health impact
following COVID-19 vaccination. For more information, visit: www.cdc.gov/vsafe.
MANDATORY REQUIREMENTS FOR PFIZER-BIONTECH COVID-19 VACCINE

ADMINISTRATION UNDER EMERGENCY USE AUTHORIZATION 3
In order to mitigate the risks of using this unapproved product under EUA and to
optimize the potential benefit of Pfizer-BioNTech COVID-19 Vaccine, the following
items are required. Use of unapproved Pfizer-BioNTech COVID-19 Vaccine for
active immunization to prevent COVID-19 under this EUA is limited to the following
(all requirements must be met):
1. Pfizer-BioNTech COVID-19 Vaccine is authorized for use in individuals

12 years of age and older.
2. The vaccination provider must communicate to the individual receiving the

Pfizer-BioNTech COVID-19 Vaccine or their caregiver, information
consistent with the “Vaccine Information Fact Sheet for Recipients and
Caregivers” prior to the individual receiving Pfizer-BioNTech COVID-19
Vaccine.
3. The vaccination provider must include vaccination information in the

state/local jurisdiction’s Immunization Information System (IIS) or other
designated system.
3 Vaccination providers administering COMIRNATY (COVID-19 Vaccine, mRNA) must adhere to the
same reporting requirements.

4. The vaccination provider is responsible for mandatory reporting of the
following to the Vaccine Adverse Event Reporting System (VAERS):
• vaccine administration errors whether or not associated with an
adverse event,
• serious adverse events* (irrespective of attribution to vaccination),
• cases of Multisystem Inflammatory Syndrome (MIS) in adults and
children, and
• cases of COVID-19 that result in hospitalization or death.
Complete and submit reports to VAERS online at

https://vaers.hhs.gov/reportevent.html. For further assistance with reporting
to VAERS call 1-800-822-7967. The reports should include the words
“Pfizer-BioNTech COVID-19 Vaccine EUA” in the description section of the
report.
5. The vaccination provider is responsible for responding to FDA requests for

information about vaccine administration errors, adverse events, cases of
MIS in adults and children, and cases of COVID-19 that result in
hospitalization or death following administration of Pfizer-BioNTech
COVID-19 Vaccine to recipients.
* Serious adverse events are defined as:

• Death;
• A life-threatening adverse event;
• Inpatient hospitalization or prolongation of existing hospitalization;
• A persistent or significant incapacity or substantial disruption of the ability to
conduct normal life functions;
• A congenital anomaly/birth defect;
• An important medical event that based on appropriate medical judgement
may jeopardize the individual and may require medical or surgical
intervention to prevent one of the outcomes listed above.
OTHER ADVERSE EVENT REPORTING TO VAERS AND PFIZER INC.
Vaccination providers may report to VAERS other adverse events that are not
required to be reported using the contact information above.
To the extent feasible, report adverse events to Pfizer Inc. using the contact
information below or by providing a copy of the VAERS form to Pfizer Inc.
Website Fax number Telephone number
www.pfizersafetyreporting.com 1-866-635-8337 1-800-438-1985

ADDITIONAL INFORMATION
For general questions, visit the website or call the telephone number provided
below.
To access the most recent Pfizer-BioNTech COVID-19 Vaccine Fact Sheets,

please scan the QR code provided below.
Global website Telephone number
www.cvdvaccine.com
1-877-829-2619
(1-877-VAX-CO19)
AVAILABLE ALTERNATIVES
COMIRNATY (COVID-19 Vaccine, mRNA) is an FDA-approved COVID-19 vaccine

made by Pfizer for BioNTech. It is approved as a 2-dose series for use in
individuals 16 years of age and older. COMIRNATY (COVID-19 Vaccine, mRNA) is
also authorized for emergency use in individuals 12 through 15 years of age and to
provide a third dose to individuals 12 years of age and older who have been
determined to have certain kinds of immunocompromise. COMIRNATY (COVID-19
Vaccine, mRNA) has the same formulation as the Pfizer-BioNTech COVID-19
Vaccine. These vaccines can be used interchangeably to provide the COVID-19
vaccination series. 4
There may be clinical trials or availability under EUA of other COVID-19 vaccines.
FEDERAL COVID-19 VACCINATION PROGRAM
This vaccine is being made available for emergency use exclusively through the
CDC COVID-19 Vaccination Program (the Vaccination Program). Healthcare
providers must enroll as providers in the Vaccination Program and comply with the
provider requirements. Vaccination providers may not charge any fee for the
vaccine and may not charge the vaccine recipient any out-of-pocket charge for
administration. However, vaccination providers may seek appropriate
reimbursement from a program or plan that covers COVID-19 vaccine
administration fees for the vaccine recipient (private insurance, Medicare,
Medicaid, Health Resources & Services Administration [HRSA] COVID-19
Uninsured Program for non-insured recipients). For information regarding provider

requirements and enrollment in the CDC COVID-19 Vaccination Program, see
https://www.cdc.gov/vaccines/covid-19/provider-enrollment.html.
Individuals becoming aware of any potential violations of the CDC COVID-19

Vaccination Program requirements are encouraged to report them to the Office of
the Inspector General, U.S. Department of Health and Human Services, at
1-800-HHS-TIPS or https://TIPS.HHS.GOV.
AUTHORITY FOR ISSUANCE OF THE EUA
The Secretary of Health and Human Services (HHS) has declared a public health
emergency that justifies the emergency use of drugs and biological products during
the COVID-19 pandemic. In response, FDA has issued an EUA for the unapproved
product, Pfizer-BioNTech COVID-19 Vaccine, for active immunization against
COVID-19 in individuals 12 years of age and older and to provide a third dose to
individuals 12 years of age and older who have been determined to have certain
kinds of immunocompromise. FDA-approved COMIRNATY is also authorized in
individuals 12 through 15 years and to provide a third dose to individuals 12 years
of age and older who have been determined to have certain kinds of
immunocompromise.
FDA issued this EUA, based on Pfizer-BioNTech’s request and submitted data.
For the authorized uses, although limited scientific information is available, based
on the totality of the scientific evidence available to date, it is reasonable to believe
that the Pfizer-BioNTech COVID-19 Vaccine and COMIRNATY may be effective for
the prevention of COVID-19 in individuals as specified in the Full EUA Prescribing
Information.
This EUA for the Pfizer-BioNTech COVID-19 Vaccine and COMIRNATY will end
when the Secretary of HHS determines that the circumstances justifying the EUA
no longer exist or when there is a change in the approval status of the product such
that an EUA is no longer needed.
For additional information about Emergency Use Authorization visit FDA at:
https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-
and-policy-framework/emergency-use-authorization.
The Countermeasures Injury Compensation Program
The Countermeasures Injury Compensation Program (CICP) is a federal program

that has been created to help pay for related costs of medical care and other
specific expenses to compensate people injured after use of certain medical
countermeasures. Medical countermeasures are specific vaccines, medications,
devices, or other items used to prevent, diagnose, or treat the public during a public
health emergency or a security threat. For more information about CICP regarding
the Pfizer-BioNTech COVID-19 Vaccine used to prevent COVID-19, visit
www.hrsa.gov/cicp, email cicp@hrsa.gov, or call: 1-855-266-2427.
Manufactured by
Pfizer Inc., New York, NY 10017
Manufactured for
BioNTech Manufacturing GmbH
An der Goldgrube 12
55131 Mainz, Germany
LAB-1450-11.4
Revised: 23 August 2021
END SHORT VERSION FACT SHEET

Long Version (Full EUA Prescribing Information) Begins On Next Page

FULL EMERGENCY USE
AUTHORIZATION (EUA) PRESCRIBING
INFORMATION
PFIZER-BIONTECH COVID-19 VACCINE

8 REQUIREMENTS AND INSTRUCTIONS FOR REPORTING
ADVERSE EVENTS AND VACCINE ADMINISTRATION
FULL EMERGENCY USE AUTHORIZATION
ERRORS
PRESCRIBING INFORMATION: CONTENTS* 10 DRUG INTERACTIONS
11 USE IN SPECIFIC POPULATIONS
1 AUTHORIZED USE 11.1 Pregnancy
2 DOSAGE AND ADMINISTRATION 11.2 Lactation
2.1 Preparation for Administration 11.3 Pediatric Use
2.2 Administration Information 11.4 Geriatric Use
2.3 Vaccination Schedule for Individuals 12 Years of Age and Older 11.5 Use in Immunocompromised
3 DOSAGE FORMS AND STRENGTHS 13 DESCRIPTION
4 CONTRAINDICATIONS 14 CLINICAL PHARMACOLOGY
5 WARNINGS AND PRECAUTIONS 14.1 Mechanism of Action
5.1 Management of Acute Allergic Reactions 18 CLINICAL TRIAL RESULTS AND SUPPORTING DATA FOR
5.2 Myocarditis and Pericarditis EUA
5.3 Syncope 18.1 Efficacy in Participants 16 Years of Age and Older
5.4 Altered Immunocompetence 18.2 Efficacy in Adolescents 12 Through 15 Years of Age
5.5 Limitation of Effectiveness 18.3 Immunogenicity in Adolescents 12 Through 15 Years of Age
6 OVERALL SAFETY SUMMARY 18.4 Immunogenicity in Solid Organ Transplant Recipients
6.1 Clinical Trials Experience 19 HOW SUPPLIED/STORAGE AND HANDLING
6.2 Post Authorization Experience 20 PATIENT COUNSELING INFORMATION
21 CONTACT INFORMATION
* Sections or subsections omitted from the full emergency use authorization

prescribing information are not listed.

FULL EMERGENCY USE AUTHORIZATION (EUA) PRESCRIBING INFORMATION
1 AUTHORIZED USE
Pfizer-BioNTech COVID-19 Vaccine is authorized for use under an Emergency Use Authorization (EUA) for
active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory
syndrome coronavirus 2 (SARS-CoV-2) in individuals 12 years of age and older.
2 DOSAGE AND ADMINISTRATION
For intramuscular injection only.
2.1 Preparation for Administration
Prior to Dilution
• The Pfizer-BioNTech COVID-19 Vaccine Multiple Dose Vial contains a volume of 0.45 mL, supplied
as a frozen suspension that does not contain preservative. Each vial must be thawed and diluted prior to
administration.
• Vials may be thawed in the refrigerator [2ºC to 8ºC (35ºF to 46ºF)] or at room temperature [up to 25ºC
(77ºF)] [see How Supplied/Storage and Handling (19)].
• Refer to thawing instructions in the panels below.
Dilution
• Dilute the vial contents using 1.8 mL of 0.9% Sodium Chloride Injection, USP (not provided) to form
the Pfizer-BioNTech COVID-19 Vaccine. Do not add more than 1.8 mL of diluent.
• ONLY use 0.9% Sodium Chloride Injection, USP as the diluent. This diluent is not packaged with the
vaccine and must be sourced separately. Do not use bacteriostatic 0.9% Sodium Chloride Injection or
any other diluent.
• After dilution, one vial contains 6 doses of 0.3 mL. Vial labels and cartons may state that after dilution,
a vial contains 5 doses of 0.3 mL. The information in this Full EUA Prescribing Information regarding
the number of doses per vial after dilution supersedes the number of doses stated on vial labels and
cartons.
• Refer to dilution and dose preparation instructions in the panels below.

THAWING PRIOR TO DILUTION
• Thaw vial(s) of Pfizer-BioNTech COVID-19
Vaccine before use either by:
o Allowing vial(s) to thaw in the refrigerator [2ºC
to 8ºC (35ºF to 46ºF)]. A carton of vials may take
up to 3 hours to thaw, and thawed vials can be
stored in the refrigerator for up to 1 month.
o Allowing vial(s) to sit at room temperature [up to
25ºC (77ºF)] for 30 minutes.
• Using either thawing method, vials must reach room
temperature before dilution and must be diluted
within 2 hours.
• Before dilution invert vaccine vial gently 10 times.

• Do not shake.
• Inspect the liquid in the vial prior to dilution. The
liquid is a white to off-white suspension and may
contain white to off-white opaque amorphous
particles.
• Do not use if liquid is discolored or if other particles
are observed.
DILUTION
• Obtain sterile 0.9% Sodium Chloride Injection,

USP. Use only this as the diluent.
• Using aseptic technique, withdraw 1.8 mL of diluent
into a transfer syringe (21-gauge or narrower
needle).
• Cleanse the vaccine vial stopper with a single-use
antiseptic swab.
• Add 1.8 mL of 0.9% Sodium Chloride Injection,
USP into the vaccine vial.

• Equalize vial pressure before removing the needle
from the vial by withdrawing 1.8 mL air into the
empty diluent syringe.
• Gently invert the vial containing the

Pfizer-BioNTech COVID-19 Vaccine 10 times to
mix.
• Do not shake.
• Inspect the vaccine in the vial.
• The vaccine will be an off-white suspension. Do not
use if vaccine is discolored or contains particulate
matter.
• Record the date and time of dilution on the

Pfizer-BioNTech COVID-19 Vaccine vial label.
• Store between 2°C to 25°C (35°F to 77°F).
• Discard any unused vaccine 6 hours after dilution.

PREPARATION OF INDIVIDUAL 0.3 mL DOSES OF PFIZER-BIONTECH COVID-19
VACCINE
• Using aseptic technique, cleanse the vial stopper

with a single-use antiseptic swab, and withdraw
0.3 mL of the Pfizer-BioNTech COVID-19 Vaccine
preferentially using low dead-volume syringes
and/or needles.
• If the amount of vaccine remaining in the vial
cannot provide a full dose of 0.3 mL, discard the
vial and any excess volume.
• Administer immediately.
2.2 Administration Information
Visually inspect each dose in the dosing syringe prior to administration. The vaccine will be an off-white
suspension. During the visual inspection,
• verify the final dosing volume of 0.3 mL.
• confirm there are no particulates and that no discoloration is observed.
• do not administer if vaccine is discolored or contains particulate matter.
Administer the Pfizer-BioNTech COVID-19 Vaccine intramuscularly.
After dilution, vials of Pfizer-BioNTech COVID-19 Vaccine contain six doses of 0.3 mL of vaccine. Low
dead-volume syringes and/or needles can be used to extract six doses from a single vial. If standard syringes
and needles are used, there may not be sufficient volume to extract a sixth dose from a single vial. Irrespective
of the type of syringe and needle:
• If the amount of vaccine remaining in the vial cannot provide a full dose of 0.3 mL, discard the vial and
any excess volume.
• Do not pool excess vaccine from multiple vials.
2.3 Vaccination Schedule for Individuals 12 Years of Age and Older
The Pfizer-BioNTech COVID-19 Vaccine is administered intramuscularly as a series of two doses (0.3 mL
each) three weeks apart.
The FDA-approved COMIRNATY (COVID-19 Vaccine, mRNA) and the EUA-authorized Pfizer-BioNTech
COVID-19 Vaccine have the same formulation and can be used interchangeably to provide the COVID-19
vaccination series. 5 There are no data available on the interchangeability of the Pfizer-BioNTech COVID-19
Vaccine or COMIRNATY (COVID-19 Vaccine, mRNA) with other COVID-19 vaccines to complete the
vaccination series. Individuals who have received one dose of Pfizer-BioNTech COVID-19 Vaccine or
COMIRNATY (COVID-19 Vaccine, mRNA should receive a second dose of Pfizer-BioNTech COVID-19
Vaccine or COMIRNATY (COVID-19 Vaccine, mRNA) to complete the vaccination series.
5
The licensed vaccine has the same formulation as the EUA-authorized vaccine and the products can be used interchangeably to
provide the vaccination series without presenting any safety or effectiveness concerns. The products are legally distinct with certain
differences that do not impact safety or effectiveness.

A third dose of the Pfizer-BioNTech COVID-19 vaccine (0.3 mL) administered at least 28 days following the
second dose of this vaccine is authorized for administration to individuals at least 12 years of age who have
undergone solid organ transplantation, or who are diagnosed with conditions that are considered to have an
equivalent level of immunocompromise.
3 DOSAGE FORMS AND STRENGTHS
Pfizer-BioNTech COVID-19 Vaccine is a suspension for injection. After preparation, a single dose is 0.3 mL.
4 CONTRAINDICATIONS
Do not administer Pfizer-BioNTech COVID-19 Vaccine to individuals with known history of a severe allergic
reaction (e.g., anaphylaxis) to any component of the Pfizer-BioNTech COVID-19 Vaccine [see Description
(13)].
5 WARNINGS AND PRECAUTIONS
5.1 Management of Acute Allergic Reactions
Appropriate medical treatment used to manage immediate allergic reactions must be immediately available in
the event an acute anaphylactic reaction occurs following administration of Pfizer-BioNTech COVID-19
Vaccine.
Monitor Pfizer-BioNTech COVID-19 Vaccine recipients for the occurrence of immediate adverse reactions
according to the Centers for Disease Control and Prevention (CDC) guidelines
(https://www.cdc.gov/vaccines/covid-19/clinical-considerations/managing-anaphylaxis.html).
5.2 Myocarditis and Pericarditis
Postmarketing data demonstrate increased risks of myocarditis and pericarditis, particularly within 7 days
following the second dose. The observed risk is higher among males under 40 years of age than among
females and older males. The observed risk is highest in males 12 through 17 years of age. Although some
cases required intensive care support, available data from short-term follow-up suggest that most individuals
have had resolution of symptoms with conservative management. Information is not yet available about
potential long-term sequelae. The CDC has published considerations related to myocarditis and pericarditis
after vaccination, including for vaccination of individuals with a history of myocarditis or pericarditis
(https://www.cdc.gov/vaccines/covid-19/clinical-considerations/myocarditis.html).
5.3 Syncope
Syncope (fainting) may occur in association with administration of injectable vaccines, in particular in
adolescents. Procedures should be in place to avoid injury from fainting.
5.4 Altered Immunocompetence
Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a

diminished immune response to the Pfizer-BioNTech COVID-19 Vaccine.

5.5 Limitation of Effectiveness
The Pfizer-BioNTech COVID-19 Vaccine may not protect all vaccine recipients.
6 OVERALL SAFETY SUMMARY
It is MANDATORY for vaccination providers to report to the Vaccine Adverse Event Reporting System
(VAERS) all vaccine administration errors, all serious adverse events, cases of Multisystem
Inflammatory Syndrome (MIS) in adults and children, and hospitalized or fatal cases of COVID-19
following vaccination with the Pfizer-BioNTech COVID-19 Vaccine. 6 To the extent feasible, provide a
copy of the VAERS form to Pfizer Inc. Please see the REQUIREMENTS AND INSTRUCTIONS FOR
REPORTING ADVERSE EVENTS AND VACCINE ADMINISTRATION ERRORS section for details
on reporting to VAERS and Pfizer Inc.
In clinical studies, adverse reactions in participants 16 years of age and older included pain at the injection site
(84.1%), fatigue (62.9%), headache (55.1%), muscle pain (38.3%), chills (31.9%), joint pain (23.6%),
fever (14.2%), injection site swelling (10.5%), injection site redness (9.5%), nausea (1.1%), malaise (0.5%), and
lymphadenopathy (0.3%).
In a clinical study, adverse reactions in adolescents 12 through 15 years of age included pain at the injection site
(90.5%), fatigue (77.5%), headache (75.5%), chills (49.2%), muscle pain (42.2%), fever (24.3%), joint pain
(20.2%), injection site swelling (9.2%), injection site redness (8.6%), lymphadenopathy (0.8%), and nausea
(0.4%).
Severe allergic reactions, including anaphylaxis, have been reported following administration of the
Pfizer-BioNTech COVID-19 Vaccine outside of clinical trials.
Myocarditis and pericarditis have been reported following administration of the Pfizer-BioNTech COVID-19
Vaccine outside of clinical trials.
6.1 Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the
clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not
reflect the rates observed in practice.
The safety of Pfizer-BioNTech COVID-19 Vaccine was evaluated in participants 12 years of age and older in
two clinical studies conducted in the United States, Europe, Turkey, South Africa, and South America.
Study BNT162-01 (Study 1) was a Phase 1/2, two-part, dose-escalation trial that enrolled 60 participants,
18 through 55 years of age. Study C4591001 (Study 2) is a Phase 1/2/3, multicenter, multinational, randomized,
saline placebo-controlled, observer-blind, dose-finding, vaccine candidate-selection (Phase 1) and efficacy
(Phase 2/3) study that has enrolled approximately 46,000 participants, 12 years of age or older. Of these,
approximately 43,448 participants (21,720 Pfizer-BioNTech COVID-19 Vaccine; 21,728 placebo) in Phase 2/3
are 16 years of age or older (including 138 and 145 adolescents 16 and 17 years of age in the vaccine and
placebo groups, respectively) and 2,260 adolescents are 12 through 15 years of age (1,131 and 1,129 in the
vaccine and placebo groups, respectively).
6
Vaccination providers administering COMIRNATY (COVID-19 Vaccine, mRNA) must adhere to the same reporting requirements.

In Study 2, all participants 12 to <16 years of age, and participants 16 years of age and older in the
reactogenicity subset, were monitored for solicited local and systemic reactions and use of antipyretic
medication after each vaccination in an electronic diary. Participants are being monitored for unsolicited
adverse events, including serious adverse events, throughout the study [from Dose 1 through 1 month (all
unsolicited adverse events) or 6 months (serious adverse events) after the last vaccination]. Tables 1 through 6
present the frequency and severity of solicited local and systemic reactions, respectively, within 7 days
following each dose of Pfizer-BioNTech COVID 19 Vaccine and placebo.
Participants 16 Years of Age and Older
At the time of the analysis of Study 2 for the EUA, 37,586 (18,801 Pfizer-BioNTech COVID-19 Vaccine and
18,785 placebo) participants 16 years of age or older had been followed for a median of 2 months after the
second dose of Pfizer-BioNTech COVID-19 Vaccine.
The safety evaluation in Study 2 is ongoing. The safety population includes participants 16 years and older
enrolled by October 9, 2020, and includes safety data accrued through November 14, 2020.
Demographic characteristics in Study 2 were generally similar with regard to age, gender, race, and ethnicity
among participants who received Pfizer-BioNTech COVID-19 Vaccine and those who received placebo.
Overall, among the total participants who received either the Pfizer-BioNTech COVID-19 Vaccine or placebo,
50.6% were male and 49.4% were female, 83.1% were White, 9.1% were Black or African American, 28.0%
were Hispanic/Latino, 4.3% were Asian, and 0.5% were American Indian/Alaska Native.
Solicited Local and Systemic Adverse Reactions
Across both age groups, 18 through 55 years of age and 56 years and older, the mean duration of pain at the
injection site after Dose 2 was 2.5 days (range 1 to 36 days), for redness 2.6 days (range 1 to 34 days), and for
swelling 2.3 days (range 1 to 34 days) for participants in the Pfizer-BioNTech COVID-19 Vaccine group.
Solicited reactogenicity data in 16 and 17 year-old participants are limited.
Table 1: Study 2 – Frequency and Percentages of Participants with Solicited Local Reactions, by
Maximum Severity, Within 7 Days After Each Dose – Participants 18 Through 55 Years of
Age‡ – Reactogenicity Subset of the Safety Population*
Pfizer-BioNTech Pfizer-BioNTech
COVID-19 Vaccine Placebo COVID-19 Vaccine Placebo
Dose 1 Dose 1 Dose 2 Dose 2
Na=2291 Na=2298 Na=2098 Na=2103
nb (%) nb (%) nb (%) nb (%)
c
Redness
Any (>2 cm) 104 (4.5) 26 (1.1) 123 (5.9) 14 (0.7)
Mild 70 (3.1) 16 (0.7) 73 (3.5) 8 (0.4)
Moderate 28 (1.2) 6 (0.3) 40 (1.9) 6 (0.3)
Severe 6 (0.3) 4 (0.2) 10 (0.5) 0 (0.0)
c
Swelling
Any (>2 cm) 132 (5.8) 11 (0.5) 132 (6.3) 5 (0.2)
Mild 88 (3.8) 3 (0.1) 80 (3.8) 3 (0.1)
Moderate 39 (1.7) 5 (0.2) 45 (2.1) 2 (0.1)
Severe 5 (0.2) 3 (0.1) 7 (0.3) 0 (0.0)

Na=2291 Na=2298 Na=2098 Na=2103
nb (%) nb (%) nb (%) nb (%)
Pain at the injection sited
Any 1904 (83.1) 322 (14.0) 1632 (77.8) 245 (11.7)
Mild 1170 (51.1) 308 (13.4) 1039 (49.5) 225 (10.7)
Moderate 710 (31.0) 12 (0.5) 568 (27.1) 20 (1.0)
Severe 24 (1.0) 2 (0.1) 25 (1.2) 0 (0.0)
Note: Reactions were collected in the electronic diary (e-diary) from Day 1 to Day 7 after vaccination.
a. N = Number of participants reporting at least 1 yes or no response for the specified reaction after the specified dose.
b. n = Number of participants with the specified reaction.
c. Mild: >2.0 to ≤5.0 cm; Moderate: >5.0 to ≤10.0 cm; Severe: >10.0 cm.
d. Mild: does not interfere with activity; Moderate: interferes with activity; Severe: prevents daily activity.
‡ Eight participants were between 16 and 17 years of age.
* Randomized participants in the safety analysis population who received at least 1 dose of the study intervention.
Table 2: Study 2 – Frequency and Percentages of Participants with Solicited Systemic Reactions, by
Maximum Severity, Within 7 Days After Each Dose – Participants 18 Through 55 Years of
Age‡ – Reactogenicity Subset of the Safety Population*
Na=2291 Na=2298 Na=2098 Na=2103
nb (%) nb (%) nb (%) nb (%)
Fever
≥38.0℃ 85 (3.7) 20 (0.9) 331 (15.8) 10 (0.5)
≥38.0℃ to 38.4℃ 64 (2.8) 10 (0.4) 194 (9.2) 5 (0.2)
>38.4℃ to 38.9℃ 15 (0.7) 5 (0.2) 110 (5.2) 3 (0.1)
>38.9℃ to 40.0℃ 6 (0.3) 3 (0.1) 26 (1.2) 2 (0.1)
>40.0℃ 0 (0.0) 2 (0.1) 1 (0.0) 0 (0.0)
c
Fatigue
Any 1085 (47.4) 767 (33.4) 1247 (59.4) 479 (22.8)
Mild 597 (26.1) 467 (20.3) 442 (21.1) 248 (11.8)
Moderate 455 (19.9) 289 (12.6) 708 (33.7) 217 (10.3)
Severe 33 (1.4) 11 (0.5) 97 (4.6) 14 (0.7)
Headachec
Any 959 (41.9) 775 (33.7) 1085 (51.7) 506 (24.1)
Mild 628 (27.4) 505 (22.0) 538 (25.6) 321 (15.3)
Moderate 308 (13.4) 251 (10.9) 480 (22.9) 170 (8.1)
Severe 23 (1.0) 19 (0.8) 67 (3.2) 15 (0.7)
Chillsc
Any 321 (14.0) 146 (6.4) 737 (35.1) 79 (3.8)
Mild 230 (10.0) 111 (4.8) 359 (17.1) 65 (3.1)
Moderate 82 (3.6) 33 (1.4) 333 (15.9) 14 (0.7)
Severe 9 (0.4) 2 (0.1) 45 (2.1) 0 (0.0)

Na=2291 Na=2298 Na=2098 Na=2103
nb (%) nb (%) nb (%) nb (%)
Vomitingd
Any 28 (1.2) 28 (1.2) 40 (1.9) 25 (1.2)
Mild 24 (1.0) 22 (1.0) 28 (1.3) 16 (0.8)
Moderate 4 (0.2) 5 (0.2) 8 (0.4) 9 (0.4)
Severe 0 (0.0) 1 (0.0) 4 (0.2) 0 (0.0)
Diarrheae
Any 255 (11.1) 270 (11.7) 219 (10.4) 177 (8.4)
Mild 206 (9.0) 217 (9.4) 179 (8.5) 144 (6.8)
Moderate 46 (2.0) 52 (2.3) 36 (1.7) 32 (1.5)
Severe 3 (0.1) 1 (0.0) 4 (0.2) 1 (0.0)
New or worsened
muscle painc
Any 487 (21.3) 249 (10.8) 783 (37.3) 173 (8.2)
Mild 256 (11.2) 175 (7.6) 326 (15.5) 111 (5.3)
Moderate 218 (9.5) 72 (3.1) 410 (19.5) 59 (2.8)
Severe 13 (0.6) 2 (0.1) 47 (2.2) 3 (0.1)
New or worsened
joint painc
Any 251 (11.0) 138 (6.0) 459 (21.9) 109 (5.2)
Mild 147 (6.4) 95 (4.1) 205 (9.8) 54 (2.6)
Moderate 99 (4.3) 43 (1.9) 234 (11.2) 51 (2.4)
Severe 5 (0.2) 0 (0.0) 20 (1.0) 4 (0.2)
Use of antipyretic or
pain medicationf 638 (27.8) 332 (14.4) 945 (45.0) 266 (12.6)
Note: Events and use of antipyretic or pain medication were collected in the electronic diary (e-diary) from Day 1 to Day 7 after
each dose.
a. N = Number of participants reporting at least 1 yes or no response for the specified event after the specified dose.
c. Mild: does not interfere with activity; Moderate: some interference with activity; Severe: prevents daily activity.
d. Mild: 1 to 2 times in 24 hours; Moderate: >2 times in 24 hours; Severe: requires intravenous hydration.
e. Mild: 2 to 3 loose stools in 24 hours; Moderate: 4 to 5 loose stools in 24 hours; Severe: 6 or more loose stools in 24 hours.
f. Severity was not collected for use of antipyretic or pain medication.
‡ Eight participants were between 16 and 17 years of age.

Table 3: Study 2 – Frequency and Percentages of Participants with Solicited Local Reactions, by
Maximum Severity, Within 7 Days After Each Dose – Participants 56 Years of Age and
Older – Reactogenicity Subset of the Safety Population*
Na=1802 Na=1792 Na=1660 Na=1646
nb (%) nb (%) nb (%) nb (%)
c
Redness
Any (>2 cm) 85 (4.7) 19 (1.1) 120 (7.2) 12 (0.7)
Mild 55 (3.1) 12 (0.7) 59 (3.6) 8 (0.5)
Moderate 27 (1.5) 5 (0.3) 53 (3.2) 3 (0.2)
Severe 3 (0.2) 2 (0.1) 8 (0.5) 1 (0.1)
c
Swelling
Any (>2 cm) 118 (6.5) 21 (1.2) 124 (7.5) 11 (0.7)
Mild 71 (3.9) 10 (0.6) 68 (4.1) 5 (0.3)
Moderate 45 (2.5) 11 (0.6) 53 (3.2) 5 (0.3)
Severe 2 (0.1) 0 (0.0) 3 (0.2) 1 (0.1)
Pain at the injection
sited
Any (>2 cm) 1282 (71.1) 166 (9.3) 1098 (66.1) 127 (7.7)
Mild 1008 (55.9) 160 (8.9) 792 (47.7) 125 (7.6)
Moderate 270 (15.0) 6 (0.3) 298 (18.0) 2 (0.1)
Severe 4 (0.2) 0 (0.0) 8 (0.5) 0 (0.0)
Table 4: Study 2 – Frequency and Percentages of Participants with Solicited Systemic Reactions, by
Maximum Severity, Within 7 Days After Each Dose – Participants 56 Years of Age and
Older – Reactogenicity Subset of the Safety Population*
N =1802
a N =1792
a N =1660
a Na=1646
n (%)
b n (%)
b n (%)
b nb (%)
Fever
≥38.0℃ 26 (1.4) 7 (0.4) 181 (10.9) 4 (0.2)
≥38.0℃ to 38.4℃ 23 (1.3) 2 (0.1) 131 (7.9) 2 (0.1)
>38.4℃ to 38.9℃ 1 (0.1) 3 (0.2) 45 (2.7) 1 (0.1)
>38.9℃ to 40.0℃ 1 (0.1) 2 (0.1) 5 (0.3) 1 (0.1)
>40.0℃ 1 (0.1) 0 (0.0) 0 (0.0) 0 (0.0)
Fatiguec
Any 615 (34.1) 405 (22.6) 839 (50.5) 277 (16.8)
Mild 373 (20.7) 252 (14.1) 351 (21.1) 161 (9.8)
Moderate 240 (13.3) 150 (8.4) 442 (26.6) 114 (6.9)
Severe 2 (0.1) 3 (0.2) 46 (2.8) 2 (0.1)

Na=1802 Na=1792 Na=1660 Na=1646
nb (%) nb (%) nb (%) nb (%)
Headachec
Any 454 (25.2) 325 (18.1) 647 (39.0) 229 (13.9)
Mild 348 (19.3) 242 (13.5) 422 (25.4) 165 (10.0)
Moderate 104 (5.8) 80 (4.5) 216 (13.0) 60 (3.6)
Severe 2 (0.1) 3 (0.2) 9 (0.5) 4 (0.2)
c
Chills
Any 113 (6.3) 57 (3.2) 377 (22.7) 46 (2.8)
Mild 87 (4.8) 40 (2.2) 199 (12.0) 35 (2.1)
Moderate 26 (1.4) 16 (0.9) 161 (9.7) 11 (0.7)
Severe 0 (0.0) 1 (0.1) 17 (1.0) 0 (0.0)
Vomitingd
Any 9 (0.5) 9 (0.5) 11 (0.7) 5 (0.3)
Mild 8 (0.4) 9 (0.5) 9 (0.5) 5 (0.3)
Moderate 1 (0.1) 0 (0.0) 1 (0.1) 0 (0.0)
Severe 0 (0.0) 0 (0.0) 1 (0.1) 0 (0.0)
Diarrheae
Any 147 (8.2) 118 (6.6) 137 (8.3) 99 (6.0)
Mild 118 (6.5) 100 (5.6) 114 (6.9) 73 (4.4)
Moderate 26 (1.4) 17 (0.9) 21 (1.3) 22 (1.3)
Severe 3 (0.2) 1 (0.1) 2 (0.1) 4 (0.2)
New or worsened
muscle painc
Any 251 (13.9) 149 (8.3) 477 (28.7) 87 (5.3)
Mild 168 (9.3) 100 (5.6) 202 (12.2) 57 (3.5)
Moderate 82 (4.6) 46 (2.6) 259 (15.6) 29 (1.8)
Severe 1 (0.1) 3 (0.2) 16 (1.0) 1 (0.1)
New or worsened joint
painc
Any 155 (8.6) 109 (6.1) 313 (18.9) 61 (3.7)
Mild 101 (5.6) 68 (3.8) 161 (9.7) 35 (2.1)
Moderate 52 (2.9) 40 (2.2) 145 (8.7) 25 (1.5)
Severe 2 (0.1) 1 (0.1) 7 (0.4) 1 (0.1)
pain medication 358 (19.9) 213 (11.9) 625 (37.7) 161 (9.8)
each dose.
From an independent report (Kamar N, Abravanel F, Marion O, et al. Three doses of an mRNA Covid-19
vaccine in solid-organ transplant recipients. N Engl J Med), in 99 individuals who had undergone various solid

organ transplant procedures (heart, kidney, liver, lung, pancreas) 97±8 months previously who received a third
vaccine dose, the adverse event profile was similar to that after the second dose and no grade 3 or grade 4
events were reported in recipients who were followed for one month following post Dose 3.
Unsolicited Adverse Events
Serious Adverse Events
In Study 2, among participants 16 through 55 years of age who had received at least 1 dose of vaccine or
placebo (Pfizer-BioNTech COVID-19 Vaccine = 10,841; placebo = 10,851), serious adverse events from
Dose 1 through up to 30 days after Dose 2 in ongoing follow-up were reported by 0.4% of Pfizer-BioNTech
COVID-19 Vaccine recipients and by 0.3% of placebo recipients. In a similar analysis, in participants 56 years
of age and older (Pfizer-BioNTech COVID-19 Vaccine = 7,960, placebo = 7,934), serious adverse events were
reported by 0.8% of Pfizer-BioNTech COVID-19 Vaccine recipients and by 0.6% of placebo recipients who
received at least 1 dose of Pfizer-BioNTech COVID-19 Vaccine or placebo, respectively. In these analyses,
91.6% of study participants had at least 30 days of follow-up after Dose 2.
Appendicitis was reported as a serious adverse event for 12 participants, and numerically higher in the vaccine
group, 8 vaccine participants and 4 placebo participants. Currently available information is insufficient to
determine a causal relationship with the vaccine. There were no other notable patterns or numerical imbalances
between treatment groups for specific categories of serious adverse events (including neurologic,
neuro-inflammatory, and thrombotic events) that would suggest a causal relationship to Pfizer-BioNTech
COVID-19 Vaccine.
Non-Serious Adverse Events
In Study 2 in which 10,841 participants 16 through 55 years of age received Pfizer-BioNTech COVID-19
Vaccine and 10,851 participants received placebo, non-serious adverse events from Dose 1 through up to
30 days after Dose 2 in ongoing follow-up were reported in 29.3% of participants who received
Pfizer-BioNTech COVID-19 Vaccine and 13.2% of participants in the placebo group, for participants who
received at least 1 dose. Overall in a similar analysis in which 7960 participants 56 years of age and older
received Pfizer-BioNTech COVID-19 Vaccine, non-serious adverse events within 30 days were reported in
23.8% of participants who received Pfizer-BioNTech COVID-19 Vaccine and 11.7% of participants in the
placebo group, for participants who received at least 1 dose. In these analyses, 91.6% of study participants had
at least 30 days of follow-up after Dose 2.
The higher frequency of reported unsolicited non-serious adverse events among Pfizer-BioNTech COVID-19
Vaccine recipients compared to placebo recipients was primarily attributed to local and systemic adverse events
reported during the first 7 days following vaccination that are consistent with adverse reactions solicited among
participants in the reactogenicity subset and presented in Tables 3 and 4. From Dose 1 through 30 days after
Dose 2, reports of lymphadenopathy were imbalanced with notably more cases in the Pfizer-BioNTech
COVID-19 Vaccine group (64) vs. the placebo group (6), which is plausibly related to vaccination. Throughout
the safety follow-up period to date, Bell’s palsy (facial paralysis) was reported by four participants in the
Pfizer-BioNTech COVID-19 Vaccine group. Onset of facial paralysis was Day 37 after Dose 1 (participant did
not receive Dose 2) and Days 3, 9, and 48 after Dose 2. No cases of Bell’s palsy were reported in the placebo
group. Currently available information is insufficient to determine a causal relationship with the vaccine. There
were no other notable patterns or numerical imbalances between treatment groups for specific categories of
non-serious adverse events (including other neurologic or neuro-inflammatory, and thrombotic events) that
would suggest a causal relationship to Pfizer-BioNTech COVID-19 Vaccine.

Adolescents 12 Through 15 Years of Age
In an analysis of Study 2, based on data up to the cutoff date of March 13, 2021, 2,260 adolescents
(1,131 Pfizer-BioNTech COVID-19 Vaccine; 1,129 placebo) were 12 through 15 years of age. Of these,
1,308 (660 Pfizer-BioNTech COVID-19 Vaccine and 648 placebo) adolescents have been followed for at least
2 months after the second dose of Pfizer-BioNTech COVID-19 Vaccine. The safety evaluation in Study 2 is
ongoing.
Demographic characteristics in Study 2 were generally similar with regard to age, gender, race, and ethnicity
among adolescents who received Pfizer-BioNTech COVID-19 Vaccine and those who received placebo.
Overall, among the adolescents who received the Pfizer-BioNTech COVID-19 Vaccine, 50.1% were male and
49.9% were female, 85.9% were White, 4.6% were Black or African American, 11.7% were Hispanic/Latino,
6.4% were Asian, and 0.4% were American Indian/Alaska Native.
Solicited Local and Systemic Adverse Reactions
The mean duration of pain at the injection site after Dose 1 was 2.4 days (range 1 to 10 days), for redness
2.4 days (range 1 to 16 days), and for swelling 1.9 days (range 1 to 5 days) for adolescents in the
Pfizer-BioNTech COVID-19 Vaccine group.
Table 5: Study 2 – Frequency and Percentages of Adolescents With Solicited Local Reactions, by
Maximum Severity, Within 7 Days After Each Dose – Adolescents 12 Through 15 Years of Age
– Safety Population*
Na=1127 Na=1127 Na=1097 Na=1078
nb (%) nb (%) nb (%) nb (%)
c
Redness
Any (>2 cm) 65 (5.8) 12 (1.1) 55 (5.0) 10 (0.9)
Mild 44 (3.9) 11 (1.0) 29 (2.6) 8 (0.7)
Moderate 20 (1.8) 1 (0.1) 26 (2.4) 2 (0.2)
Severe 1 (0.1) 0 (0.0) 0 (0.0) 0 (0.0)
c
Swelling
Any (>2 cm) 78 (6.9) 11 (1.0) 54 (4.9) 6 (0.6)
Mild 55 (4.9) 9 (0.8) 36 (3.3) 4 (0.4)
Moderate 23 (2.0) 2 (0.2) 18 (1.6) 2 (0.2)
Severe 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0)

Na=1127 Na=1127 Na=1097 Na=1078
nb (%) nb (%) nb (%) nb (%)
Pain at the injection
sited
Any 971 (86.2) 263 (23.3) 866 (78.9) 193 (17.9)
Mild 467 (41.4) 227 (20.1) 466 (42.5) 164 (15.2)
Moderate 493 (43.7) 36 (3.2) 393 (35.8) 29 (2.7)
Severe 11 (1.0) 0 (0.0) 7 (0.6) 0 (0.0)
Table 6: Study 2 – Frequency and Percentages of Adolescents with Solicited Systemic Reactions, by
Maximum Severity, Within 7 Days After Each Dose – Adolescents 12 Through 15 Years of Age
– Safety Population*
N =1127
a N =1127
a N =1097
a Na=1078
n (%)
b n (%)
b n (%)
b nb (%)
Fever
≥38.0℃ 114 (10.1) 12 (1.1) 215 (19.6) 7 (0.6)
≥38.0℃ to 38.4℃ 74 (6.6) 8 (0.7) 107 (9.8) 5 (0.5)
>38.4℃ to 38.9℃ 29 (2.6) 2 (0.2) 83 (7.6) 1 (0.1)
>38.9℃ to 40.0℃ 10 (0.9) 2 (0.2) 25 (2.3) 1 (0.1)
>40.0℃ 1 (0.1) 0 (0.0) 0 (0.0) 0 (0.0)
Fatiguec
Any 677 (60.1) 457 (40.6) 726 (66.2) 264 (24.5)
Mild 278 (24.7) 250 (22.2) 232 (21.1) 133 (12.3)
Moderate 384 (34.1) 199 (17.7) 468 (42.7) 127 (11.8)
Severe 15 (1.3) 8 (0.7) 26 (2.4) 4 (0.4)
c
Headache
Any 623 (55.3) 396 (35.1) 708 (64.5) 263 (24.4)
Mild 361 (32.0) 256 (22.7) 302 (27.5) 169 (15.7)
Moderate 251 (22.3) 131 (11.6) 384 (35.0) 93 (8.6)
Severe 11 (1.0) 9 (0.8) 22 (2.0) 1 (0.1)
c
Chills
Any 311 (27.6) 109 (9.7) 455 (41.5) 73 (6.8)
Mild 195 (17.3) 82 (7.3) 221 (20.1) 52 (4.8)
Moderate 111 (9.8) 25 (2.2) 214 (19.5) 21 (1.9)
Severe 5 (0.4) 2 (0.2) 20 (1.8) 0 (0.0)

Na=1127 Na=1127 Na=1097 Na=1078
nb (%) nb (%) nb (%) nb (%)
Vomitingd
Any 31 (2.8) 10 (0.9) 29 (2.6) 12 (1.1)
Mild 30 (2.7) 8 (0.7) 25 (2.3) 11 (1.0)
Moderate 0 (0.0) 2 (0.2) 4 (0.4) 1 (0.1)
Severe 1 (0.1) 0 (0.0) 0 (0.0) 0 (0.0)
Diarrheae
Any 90 (8.0) 82 (7.3) 65 (5.9) 43 (4.0)
Mild 77 (6.8) 72 (6.4) 59 (5.4) 38 (3.5)
Moderate 13 (1.2) 10 (0.9) 6 (0.5) 5 (0.5)
Severe 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0)
New or worsened
muscle painc
Any 272 (24.1) 148 (13.1) 355 (32.4) 90 (8.3)
Mild 125 (11.1) 88 (7.8) 152 (13.9) 51 (4.7)
Moderate 145 (12.9) 60 (5.3) 197 (18.0) 37 (3.4)
Severe 2 (0.2) 0 (0.0) 6 (0.5) 2 (0.2)
New or worsened joint
painc
Any 109 (9.7) 77 (6.8) 173 (15.8) 51 (4.7)
Mild 66 (5.9) 50 (4.4) 91 (8.3) 30 (2.8)
Moderate 42 (3.7) 27 (2.4) 78 (7.1) 21 (1.9)
Severe 1 (0.1) 0 (0.0) 4 (0.4) 0 (0.0)
pain medicationf 413 (36.6) 111 (9.8) 557 (50.8) 95 (8.8)
each dose.
f. Severity was not collected for use of antipyretic or pain medication.
Unsolicited Adverse Events
In the following analyses of Study 2 in adolescents 12 through 15 years of age (1,131 of whom received
Pfizer-BioNTech COVID-19 Vaccine and 1,129 of whom received placebo), 98.3% of study participants had at
least 30 days of follow-up after Dose 2.
Serious Adverse Events
Serious adverse events from Dose 1 through up to 30 days after Dose 2 in ongoing follow-up were reported by
0.4% of Pfizer-BioNTech COVID-19 Vaccine recipients and by 0.1% of placebo recipients. There were no
notable patterns or numerical imbalances between treatment groups for specific categories of serious adverse
events that would suggest a causal relationship to Pfizer-BioNTech COVID-19 Vaccine.

Non-Serious Adverse Events
Non-serious adverse events from Dose 1 through up to 30 days after Dose 2 in ongoing follow-up were reported
by 5.8% of Pfizer-BioNTech COVID-19 Vaccine recipients and by 5.8% of placebo recipients. From Dose 1
through 30 days after Dose 2, reports of lymphadenopathy plausibly related to the study intervention were
imbalanced, with notably more cases in the Pfizer-BioNTech COVID-19 Vaccine group (7) vs. the placebo
group (1). There were no other notable patterns or numerical imbalances between treatment groups for specific
categories of non-serious adverse events that would suggest a causal relationship to Pfizer-BioNTech
COVID-19 Vaccine.
6.2 Post Authorization Experience
The following adverse reactions have been identified during post authorization use of Pfizer-BioNTech
COVID-19 Vaccine. Because these reactions are reported voluntarily, it is not always possible to reliably
estimate their frequency or establish a causal relationship to vaccine exposure.
Cardiac Disorders: myocarditis, pericarditis

Gastrointestinal Disorders: diarrhea, vomiting
Immune System Disorders: severe allergic reactions, including anaphylaxis, and other hypersensitivity reactions
(e.g., rash, pruritus, urticaria, angioedema)
Musculoskeletal and Connective Tissue Disorders: pain in extremity (arm)
8 REQUIREMENTS AND INSTRUCTIONS FOR REPORTING ADVERSE EVENTS AND

VACCINE ADMINISTRATION ERRORS 7
See Overall Safety Summary (Section 6) for additional information.
The vaccination provider enrolled in the federal COVID-19 Vaccination Program is responsible for
MANDATORY reporting of the listed events following Pfizer-BioNTech COVID-19 Vaccine to the Vaccine
Adverse Event Reporting System (VAERS):
• Vaccine administration errors whether or not associated with an adverse event
• Serious adverse events* (irrespective of attribution to vaccination)
• Cases of Multisystem Inflammatory Syndrome (MIS) in children and adults
• Cases of COVID-19 that result in hospitalization or death
*
Serious adverse events are defined as:
• Death
• A life-threatening adverse event
• Inpatient hospitalization or prolongation of existing hospitalization
• A persistent or significant incapacity or substantial disruption of the ability to conduct normal life
functions
• A congenital anomaly/birth defect
• An important medical event that based on appropriate medical judgement may jeopardize the individual
and may require medical or surgical intervention to prevent one of the outcomes listed above
7
Vaccination providers administering COMIRNATY (COVID-19 Vaccine, mRNA) must adhere to the same reporting requirements.

Instructions for Reporting to VAERS
The vaccination provider enrolled in the federal COVID-19 Vaccination Program should complete and submit a
VAERS form to FDA using one of the following methods:
• Complete and submit the report online: https://vaers.hhs.gov/reportevent.html, or
• If you are unable to submit this form electronically, you may fax it to VAERS at 1-877-721-0366. If
you need additional help submitting a report you may call the VAERS toll-free information line at
1-800-822-7967 or send an email to info@vaers.org.
IMPORTANT: When reporting adverse events or vaccine administration errors to VAERS, please
complete the entire form with detailed information. It is important that the information reported to FDA
be as detailed and complete as possible. Information to include:
• Patient demographics (e.g., patient name, date of birth)
• Pertinent medical history
• Pertinent details regarding admission and course of illness
• Concomitant medications
• Timing of adverse event(s) in relationship to administration of the Pfizer-BioNTech COVID-19
Vaccine
• Pertinent laboratory and virology information
• Outcome of the event and any additional follow-up information if it is available at the time of the
VAERS report. Subsequent reporting of follow-up information should be completed if additional
details become available.
The following steps are highlighted to provide the necessary information for safety tracking:
1. In Box 17, provide information on Pfizer-BioNTech COVID-19 Vaccine and any other vaccines
administered on the same day; and in Box 22, provide information on any other vaccines received within
one month prior.
2. In Box 18, description of the event:
a. Write “Pfizer-BioNTech COVID-19 Vaccine EUA” as the first line.
b. Provide a detailed report of vaccine administration error and/or adverse event. It is important to
provide detailed information regarding the patient and adverse event/medication error for
ongoing safety evaluation of this unapproved vaccine. Please see information to include listed
above.
3. Contact information:
a. In Box 13, provide the name and contact information of the prescribing healthcare provider or
institutional designee who is responsible for the report.
b. In Box 14, provide the name and contact information of the best doctor/healthcare professional
to contact about the adverse event.
c. In Box 15, provide the address of the facility where vaccine was given (NOT the healthcare
provider’s office address).
Other Reporting Instructions
Vaccination providers may report to VAERS other adverse events that are not required to be reported using the
contact information above.

To the extent feasible, report adverse events to Pfizer Inc. using the contact information below or by providing a
copy of the VAERS form to Pfizer Inc.
Website Fax number Telephone number
www.pfizersafetyreporting.com 1-866-635-8337 1-800-438-1985
10 DRUG INTERACTIONS
There are no data to assess the concomitant administration of the Pfizer-BioNTech COVID-19 Vaccine with
other vaccines.
11 USE IN SPECIFIC POPULATIONS
11.1 Pregnancy
Risk Summary
All pregnancies have a risk of birth defect, loss, or other adverse outcomes. In the US general population, the
estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to
4% and 15% to 20%, respectively. Available data on Pfizer-BioNTech COVID-19 Vaccine administered to
pregnant women are insufficient to inform vaccine-associated risks in pregnancy.
In a reproductive and developmental toxicity study, 0.06 mL of a vaccine formulation containing the same
quantity of nucleoside-modified messenger ribonucleic acid (mRNA) (30 mcg) and other ingredients included
in a single human dose of Pfizer-BioNTech COVID-19 Vaccine was administered to female rats by the
intramuscular route on four occasions: 21 and 14 days prior to mating, and on gestation days 9 and 20. No
vaccine-related adverse effects on female fertility, fetal development, or postnatal development were reported in
the study.
11.2 Lactation
Risk Summary
Data are not available to assess the effects of Pfizer-BioNTech COVID-19 Vaccine on the breastfed infant or on
milk production/excretion.
11.3 Pediatric Use
Emergency Use Authorization of Pfizer-BioNTech COVID-19 Vaccine in adolescents 12 through 18 years of

age is based on safety and effectiveness data in this age group and in adults.
Emergency Use Authorization of Pfizer-BioNTech COVID-19 Vaccine does not include use in individuals
younger than 12 years of age.
11.4 Geriatric Use
Clinical studies of Pfizer-BioNTech COVID-19 Vaccine include participants 65 years of age and older and their
data contributes to the overall assessment of safety and efficacy [see Overall Safety Summary (6.1) and Clinical

Trial Results and Supporting Data for EUA (18.1)]. Of the total number of Pfizer-BioNTech COVID-19
Vaccine recipients in Study 2 (N=20,033), 21.4% (n=4,294) were 65 years of age and older and 4.3% (n=860)
were 75 years of age and older.
11.5 Use in Immunocompromised
vaccine in solid-organ transplant recipients. N Engl J Med), safety and effectiveness of a third dose of the
Pfizer-BioNTech COVID-19 vaccine have been evaluated in persons that received solid organ transplants. The
administration of a third dose of vaccine appears to be only moderately effective in increasing potentially
protective antibody titers. Patients should still be counselled to maintain physical precautions to help prevent
COVID-19. In addition, close contacts of immunocompromised persons should be vaccinated as appropriate for
their health status.
13 DESCRIPTION
The Pfizer-BioNTech COVID-19 Vaccine is supplied as a frozen suspension in multiple dose vials; each vial
must be diluted with 1.8 mL of sterile 0.9% Sodium Chloride Injection, USP prior to use to form the vaccine.
Each dose of the Pfizer-BioNTech COVID-19 Vaccine contains 30 mcg of a nucleoside-modified messenger
RNA (modRNA) encoding the viral spike (S) glycoprotein of SARS-CoV-2.
Each dose of the Pfizer-BioNTech COVID-19 Vaccine also includes the following ingredients: lipids (0.43 mg
(4-hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis(2-hexyldecanoate), 0.05 mg 2[(polyethylene glycol)-2000]-
N,N-ditetradecylacetamide, 0.09 mg 1,2-distearoyl-sn-glycero-3-phosphocholine, and 0.2 mg cholesterol),
0.01 mg potassium chloride, 0.01 mg monobasic potassium phosphate, 0.36 mg sodium chloride, 0.07 mg
dibasic sodium phosphate dihydrate, and 6 mg sucrose. The diluent (0.9% Sodium Chloride Injection, USP)
contributes an additional 2.16 mg sodium chloride per dose.
The Pfizer-BioNTech COVID-19 Vaccine does not contain preservative. The vial stoppers are not made with
natural rubber latex.
14 CLINICAL PHARMACOLOGY
14.1 Mechanism of Action
The modRNA in the Pfizer-BioNTech COVID-19 Vaccine is formulated in lipid particles, which enable
delivery of the RNA into host cells to allow expression of the SARS-CoV-2 S antigen. The vaccine elicits an
immune response to the S antigen, which protects against COVID-19.
18 CLINICAL TRIAL RESULTS AND SUPPORTING DATA FOR EUA
18.1 Efficacy in Participants 16 Years of Age and Older
Study 2 is a multicenter, multinational, Phase 1/2/3, randomized, placebo-controlled, observer-blind,

dose-finding, vaccine candidate-selection, and efficacy study in participants 12 years of age and older.
Randomization was stratified by age: 12 through 15 years of age, 16 through 55 years of age, or 56 years of age
and older, with a minimum of 40% of participants in the ≥56-year stratum. The study excluded participants who
were immunocompromised and those who had previous clinical or microbiological diagnosis of COVID-19.
Participants with preexisting stable disease, defined as disease not requiring significant change in therapy or
hospitalization for worsening disease during the 6 weeks before enrollment, were included as were participants

with known stable infection with human immunodeficiency virus (HIV), hepatitis C virus (HCV), or hepatitis B
virus (HBV).
In the Phase 2/3 portion of Study 2, based on data accrued through November 14, 2020, approximately
44,000 participants 12 years of age and older were randomized equally and received 2 doses of
Pfizer-BioNTech COVID-19 Vaccine or placebo separated by 21 days. Participants are planned to be followed
for up to 24 months, for assessments of safety and efficacy against COVID-19.
The population for the analysis of the primary efficacy endpoint included, 36,621 participants 12 years of age
and older (18,242 in the Pfizer-BioNTech COVID-19 Vaccine group and 18,379 in the placebo group) who did
not have evidence of prior infection with SARS-CoV-2 through 7 days after the second dose. Table 7 presents
the specific demographic characteristics in the studied population.
Table 7: Demographics (population for the primary efficacy endpoint)a

Pfizer-BioNTech
COVID-19 Vaccine Placebo
(N=18,242) (N=18,379)
n (%) n (%)
Sex
Male 9318 (51.1) 9225 (50.2)
Female 8924 (48.9) 9154 (49.8)
Age (years)
Mean (SD) 50.6 (15.70) 50.4 (15.81)
Median 52.0 52.0
Min, max (12, 89) (12, 91)
Age group
≥12 through 15 yearsb 46 (0.3) 42 (0.2)
≥16 through 17 years 66 (0.4) 68 (0.4)
≥16 through 64 years 14,216 (77.9) 14,299 (77.8)
≥65 through 74 years 3176 (17.4) 3226 (17.6)
≥75 years 804 (4.4) 812 (4.4)
Race
White 15,110 (82.8) 15,301 (83.3)
Black or African American 1617 (8.9) 1617 (8.8)
American Indian or Alaska Native 118 (0.6) 106 (0.6)
Asian 815 (4.5) 810 (4.4)
Native Hawaiian or other Pacific Islander 48 (0.3) 29 (0.2)
c
Other 534 (2.9) 516 (2.8)
Ethnicity
Hispanic or Latino 4886 (26.8) 4857 (26.4)
Not Hispanic or Latino 13,253 (72.7) 13,412 (73.0)
Not reported 103 (0.6) 110 (0.6)
Comorbiditiesd
Yes 8432 (46.2) 8450 (46.0)
No 9810 (53.8) 9929 (54.0)
a. All eligible randomized participants who receive all vaccination(s) as randomized within the predefined window, have no other
important protocol deviations as determined by the clinician, and have no evidence of SARS-CoV-2 infection prior to 7 days
after Dose 2.
b. 100 participants 12 through 15 years of age with limited follow-up in the randomized population received at least one dose
(49 in the vaccine group and 51 in the placebo group). Some of these participants were included in the efficacy evaluation

Pfizer-BioNTech
(N=18,242) (N=18,379)
n (%) n (%)
depending on the population analyzed. They contributed to exposure information but with no confirmed COVID-19 cases, and
did not affect efficacy conclusions.
c. Includes multiracial and not reported.
d. Number of participants who have 1 or more comorbidities that increase the risk of severe COVID-19 disease
• Chronic lung disease (e.g., emphysema and chronic bronchitis, idiopathic pulmonary fibrosis, and cystic fibrosis) or
moderate to severe asthma
• Significant cardiac disease (e.g., heart failure, coronary artery disease, congenital heart disease, cardiomyopathies, and
pulmonary hypertension)
• Obesity (body mass index ≥30 kg/m2)
• Diabetes (Type 1, Type 2 or gestational)
• Liver disease
• Human Immunodeficiency Virus (HIV) infection (not included in the efficacy evaluation)
The population in the primary efficacy analysis included all participants 12 years of age and older who had been
enrolled from July 27, 2020, and followed for the development of COVID-19 through November 14, 2020.
Participants 18 through 55 years of age and 56 years of age and older began enrollment from July 27, 2020,
16 through 17 years of age began enrollment from September 16, 2020, and 12 through 15 years of age began
enrollment from October 15, 2020.
The vaccine efficacy information is presented in Table 8.
Table 8: Vaccine Efficacy – First COVID-19 Occurrence From 7 Days After Dose 2, by Age
Subgroup – Participants Without Evidence of Infection and Participants With or Without
Evidence of Infection Prior to 7 Days After Dose 2 – Evaluable Efficacy (7 Days) Population
First COVID-19 occurrence from 7 days after Dose 2 in participants without evidence of prior
SARS-CoV-2 infection*
Pfizer-BioNTech
Na=18,198 Na=18,325
Cases Cases
n1b n1b Vaccine Efficacy %
Subgroup Surveillance Time (n2 ) Surveillance Time (n2 )
c d c d (95% CI)
8 162
All subjectse 2.214 (17,411) 2.222 (17,511) 95.0 (90.3, 97.6)f
7 143
16 through 64 years 1.706 (13,549) 1.710 (13,618) 95.1 (89.6, 98.1)g
1 19
65 years and older 0.508 (3848) 0.511 (3880) 94.7 (66.7, 99.9)g

First COVID-19 occurrence from 7 days after Dose 2 in participants with or without evidence of prior
SARS-CoV-2 infection
Pfizer-BioNTech
Na=19,965 Na=20,172
Cases Cases
Subgroup Surveillance Time (n2 ) Surveillance Time (n2 )
c d c d (95% CI)
9 169
All subjectse 2.332 (18,559) 2.345 (18,708) 94.6 (89.9, 97.3)f
8 150
16 through 64 years 1.802 (14,501) 1.814 (14,627) 94.6 (89.1, 97.7)g
1 19
65 years and older 0.530 (4044) 0.532 (4067) 94.7 (66.8, 99.9)g
Note: Confirmed cases were determined by Reverse Transcription-Polymerase Chain Reaction (RT-PCR) and at least 1 symptom
consistent with COVID-19 (symptoms included: fever; new or increased cough; new or increased shortness of breath; chills; new or
increased muscle pain; new loss of taste or smell; sore throat; diarrhea; vomiting).
* Participants who had no evidence of past SARS-CoV-2 infection (i.e., N-binding antibody [serum] negative at Visit 1 and
SARS-CoV-2 not detected by NAAT [nasal swab] at Visits 1 and 2), and had negative NAAT (nasal swab) at any unscheduled
visit prior to 7 days after Dose 2 were included in the analysis.
a. N = Number of participants in the specified group.
b. n1 = Number of participants meeting the endpoint definition.
c. Total surveillance time in 1000 person-years for the given endpoint across all participants within each group at risk for the
endpoint. Time period for COVID-19 case accrual is from 7 days after Dose 2 to the end of the surveillance period.
d. n2 = Number of participants at risk for the endpoint.
e. No confirmed cases were identified in adolescents 12 through 15 years of age.
f. Credible interval for vaccine efficacy (VE) was calculated using a beta-binomial model with a beta (0.700102, 1) prior for θ=r(1-
VE)/(1+r(1-VE)), where r is the ratio of surveillance time in the active vaccine group over that in the placebo group.
g. Confidence interval (CI) for vaccine efficacy is derived based on the Clopper and Pearson method adjusted to the surveillance
time.
18.2 Efficacy in Adolescents 12 Through 15 Years of Age
A descriptive efficacy analysis of Study 2 has been performed in approximately 2,200 adolescents 12 through
15 years of age evaluating confirmed COVID-19 cases accrued up to a data cutoff date of March 13, 2021.
The efficacy information in adolescents 12 through 15 years of age is presented in Table 9.

Table 9: Vaccine Efficacy – First COVID-19 Occurrence From 7 Days After Dose 2: Without Evidence
of Infection and With or Without Evidence of Infection Prior to 7 Days After Dose 2 – Blinded
Placebo-Controlled Follow-up Period, Adolescents 12 Through 15 Years of Age Evaluable
Efficacy (7 Days) Population
First COVID-19 occurrence from 7 days after Dose 2 in adolescents 12 through 15 years of age without
evidence of prior SARS-CoV-2 infection*
Pfizer-BioNTech
N =1005
a Na=978
Cases Cases
Surveillance Time (n2 ) Surveillance Time (n2 )
c d c d (95% CIe)
Adolescents 0 16
12 through 15 years of age 0.154 (1001) 0.147 (972) 100.0 (75.3, 100.0)
First COVID-19 occurrence from 7 days after Dose 2 in adolescents 12 through 15 years of age with or
without evidence of prior SARS-CoV-2 infection
Pfizer-BioNTech Placebo
COVID-19 Vaccine
Na=1119 Na=1110
Cases Cases
Surveillance Time (n2 ) Surveillance Time (n2 )
c d c d (95% CIe)
Adolescents 0 18
12 through 15 years of age 0.170 (1109) 0.163 (1094) 100.0 (78.1, 100.0)
Note: Confirmed cases were determined by Reverse Transcription-Polymerase Chain Reaction (RT-PCR) and at least 1 symptom
consistent with COVID-19 (symptoms included: fever; new or increased cough; new or increased shortness of breath; chills; new or
increased muscle pain; new loss of taste or smell; sore throat; diarrhea; vomiting).
* Participants who had no evidence of past SARS-CoV-2 infection (i.e., N-binding antibody [serum] negative at Visit 1 and
SARS-CoV-2 not detected by NAAT [nasal swab] at Visits 1 and 2), and had negative NAAT (nasal swab) at any unscheduled
visit prior to 7 days after Dose 2 were included in the analysis.
a. N = Number of participants in the specified group.
b. n1 = Number of participants meeting the endpoint definition.
c. Total surveillance time in 1000 person-years for the given endpoint across all participants within each group at risk for the
endpoint. Time period for COVID-19 case accrual is from 7 days after Dose 2 to the end of the surveillance period.
d. n2 = Number of participants at risk for the endpoint.
e. Confidence interval (CI) for vaccine efficacy is derived based on the Clopper and Pearson method adjusted for surveillance time.
18.3 Immunogenicity in Adolescents 12 Through 15 Years of Age
In Study 2, an analysis of SARS-CoV-2 50% neutralizing titers 1 month after Dose 2 in a randomly selected
subset of participants demonstrated non-inferior immune responses (within 1.5-fold) comparing adolescents
12 through 15 years of age to participants 16 through 25 years of age who had no serological or virological
evidence of past SARS-CoV-2 infection up to 1 month after Dose 2 (Table 10).

Table 10: Summary of Geometric Mean Ratio for 50% Neutralizing Titer – Comparison of Adolescents
12 Through 15 Years of Age to Participants 16 Through 25 Years of Age (Immunogenicity
Subset) –Participants Without Evidence of Infection up to 1 Month After Dose 2 – Dose 2
Evaluable Immunogenicity Population
12 Through 15 Years 16 Through 25 Years 12 Through 15 Years/
na=190 na=170 16 Through 25 Years
Met
Noninferiority
Time GMTc GMTc GMRd Objectivee
Assay Point b (95% CI )c (95% CI )c (95% CI )d (Y/N)
SARS-CoV-2
neutralization 1 month
assay - NT50 after 1239.5 705.1 1.76
(titer)f Dose 2 (1095.5, 1402.5) (621.4, 800.2) (1.47, 2.10) Y
Abbreviations: CI = confidence interval; GMR = geometric mean ratio; GMT = geometric mean titer; LLOQ = lower limit of
quantitation; NAAT = nucleic-acid amplification test; NT50 = 50% neutralizing titer; SARS-CoV-2 = severe acute respiratory
syndrome coronavirus 2.
Note: Participants who had no serological or virological evidence (up to 1 month after receipt of the last dose) of past SARS-CoV-2
infection (i.e., N-binding antibody [serum] negative at Visit 1 and SARS-CoV-2 not detected by NAAT [nasal swab] at Visits 1 and
2), and had negative NAAT (nasal swab) at any unscheduled visit up to 1 month after Dose 2 were included in the analysis.
a. n = Number of participants with valid and determinate assay results for the specified assay at the given dose/sampling time
point.
b. Protocol-specified timing for blood sample collection.
c. GMTs and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs
(based on the Student t distribution). Assay results below the LLOQ were set to 0.5 × LLOQ.
d. GMRs and 2-sided 95% CIs were calculated by exponentiating the mean difference of the logarithms of the titers (Group 1
[12 through 15 years of age] – Group 2 [16 through 25 years of age]) and the corresponding CI (based on the Student t
distribution).
e. Noninferiority is declared if the lower bound of the 2-sided 95% CI for the GMR is greater than 0.67.
f. SARS-CoV-2 50% neutralization titers (NT50) were determined using the SARS-CoV-2 mNeonGreen Virus
Microneutralization Assay. The assay uses a fluorescent reporter virus derived from the USA_WA1/2020 strain and virus
neutralization is read on Vero cell monolayers. The sample NT50 is defined as the reciprocal serum dilution at which 50% of
the virus is neutralized.
18.4 Immunogenicity in Solid Organ Transplant Recipients
vaccine in solid-organ transplant recipients. N Engl J Med), a single arm study has been conducted in
101 individuals who had undergone various solid organ transplant procedures (heart, kidney, liver, lung,
pancreas) 97±8 months previously. A third dose of the Pfizer-BioNTech COVID-19 vaccine was administered
to 99 of these individuals approximately 2 months after they had received a second dose. Among the 59 patients
who had been seronegative before the third dose, 26 (44%) were seropositive at 4 weeks after the third dose. All
40 patients who had been seropositive before the third dose were still seropositive 4 weeks later. The prevalence
of anti-SARS-CoV-2 antibodies was 68% (67 of 99 patients) 4 weeks after the third dose.
19 HOW SUPPLIED/STORAGE AND HANDLING
Pfizer-BioNTech COVID-19 Vaccine Suspension for Intramuscular Injection, Multiple Dose Vials are supplied
in a carton containing 25 multiple dose vials (NDC 59267-1000-3) or 195 multiple dose vials
(NDC 59267-1000-2). After dilution, one vial contains 6 doses of 0.3 mL. Vial labels and cartons may state that
after dilution, a vial contains 5 doses of 0.3 mL. The information in this Full EUA Prescribing Information

regarding the number of doses per vial after dilution supersedes the number of doses stated on vial labels and
cartons.
During storage, minimize exposure to room light, and avoid exposure to direct sunlight and ultraviolet light.
Do not refreeze thawed vials.
Frozen Vials Prior to Use
Cartons of Pfizer-BioNTech COVID-19 Vaccine Multiple Dose Vials arrive in thermal containers with dry ice.
Once received, remove the vial cartons immediately from the thermal container and preferably store in an
ultra-low temperature freezer between -90ºC to -60ºC (-130ºF to -76ºF) until the expiry date printed on the
label. This information in the package insert supersedes the storage conditions printed on the vial cartons.
Cartons and vials of Pfizer-BioNTech COVID-19 Vaccine with an expiry date of August 2021 through
February 2022 printed on the label may remain in use for 3 months beyond the printed date as long as approved
storage conditions between -90ºC to -60ºC (-130ºF to -76ºF) have been maintained. Updated expiry dates are
shown below.
Printed Expiry Date Updated Expiry Date

August 2021  November 2021
September 2021  December 2021
October 2021  January 2022
November 2021  February 2022
December 2021  March 2022
January 2022  April 2022
February 2022  May 2022
If not stored between -90ºC to -60ºC (-130ºF to -76ºF), vials may be stored at -25°C to -15°C (-13°F to 5°F) for
up to 2 weeks. Vials must be kept frozen and protected from light, in the original cartons, until ready to use.
Vials stored at -25°C to -15°C (-13°F to 5°F) for up to 2 weeks may be returned one time to the recommended
storage condition of -90ºC to -60ºC (-130ºF to -76ºF). Total cumulative time the vials are stored at -25°C
to -15°C (-13°F to 5°F) should be tracked and should not exceed 2 weeks.
If an ultra-low temperature freezer is not available, the thermal container in which the Pfizer-BioNTech
COVID-19 Vaccine arrives may be used as temporary storage when consistently re-filled to the top of the
container with dry ice. Refer to the re-icing guidelines packed in the original thermal container for instructions
regarding the use of the thermal container for temporary storage. The thermal container maintains a temperature
range of -90ºC to -60ºC (-130ºF to -76ºF). Storage of the vials between -96°C to -60°C (-141°F to -76°F) is not
considered an excursion from the recommended storage condition.
Transportation of Frozen Vials
If local redistribution is needed and full cartons containing vials cannot be transported at -90°C to -60°C
(-130°F to -76°F), vials may be transported at -25°C to -15°C (-13°F to 5°F). Any hours used for transport
at -25°C to -15°C (-13°F to 5°F) count against the 2-week limit for storage at -25°C to -15°C (-13°F to 5°F).
Frozen vials transported at -25°C to -15°C (-13°F to 5°F) may be returned one time to the recommended storage
condition of -90ºC to -60ºC (-130ºF to -76ºF).

Thawed Vials Before Dilution
Thawed Under Refrigeration
Thaw and then store undiluted vials in the refrigerator [2ºC to 8ºC (35ºF to 46ºF)] for up to 1 month. A carton of
25 vials or 195 vials may take up to 2 or 3 hours, respectively, to thaw in the refrigerator, whereas a fewer
number of vials will thaw in less time.
Thawed at Room Temperature
For immediate use, thaw undiluted vials at room temperature [up to 25ºC (77ºF)] for 30 minutes. Thawed vials
can be handled in room light conditions.
Vials must reach room temperature before dilution.
Undiluted vials may be stored at room temperature for no more than 2 hours.
Transportation of Thawed Vials
Available data support transportation of one or more thawed vials at 2°C to 8°C (35°F to 46°F) for up to
12 hours.
Vials After Dilution
After dilution, store vials between 2°C to 25°C (35°F to 77°F) and use within 6 hours from the time of dilution.
During storage, minimize exposure to room light, and avoid exposure to direct sunlight and ultraviolet light.
Any vaccine remaining in vials must be discarded after 6 hours. Do not refreeze.
20 PATIENT COUNSELING INFORMATION
Advise the recipient or caregiver to read the Vaccine Information Fact Sheet for Recipients and Caregivers.
The vaccination provider must include vaccination information in the state/local jurisdiction’s Immunization
Information System (IIS) or other designated system. Advise recipient or caregiver that more information about
IISs can be found at: https://www.cdc.gov/vaccines/programs/iis/about.html.
21 CONTACT INFORMATION
For general questions, visit the website or call the telephone number provided below.
Website Telephone number

www.cvdvaccine.com
1-877-829-2619
(1-877-VAX-CO19)

This Full EUA Prescribing Information may have been updated. For the most recent Full EUA Prescribing
Information, please see www.cvdvaccine.com.
Manufactured by
Pfizer Inc., New York, NY 10017
Manufactured for
BioNTech Manufacturing GmbH
An der Goldgrube 12
55131 Mainz, Germany
LAB-1457-11.4
Revised: 23 August 2021

Final - EUA - Full PI - HCP Fact Sheet Pfizer-BioNTECH COVID-19 Vaccine

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Final - EUA - Full PI - HCP Fact Sheet Pfizer-BioNTECH COVID-19 Vaccine

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FACT SHEET FOR HEALTHCARE PROVIDERS ADMINISTERING VACCINE

EMERGENCY USE AUTHORIZATION (EUA) OF

COMIRNATY (COVID-19 Vaccine, mRNA) is an FDA-approved COVID-19

The FDA-approved COMIRNATY (COVID-19 Vaccine, mRNA) and the

SUMMARY OF INSTRUCTIONS FOR COVID-19 VACCINATION PROVIDERS

Vaccination providers enrolled in the federal COVID-19 Vaccination Program must

The Pfizer-BioNTech COVID-19 Vaccine is a suspension for intramuscular injection

A third dose of the Pfizer-BioNTech COVID-19 Vaccine (0.3 mL) administered at

Revised: 23 August 2021 1

Coronavirus disease 2019 (COVID-19) is an infectious disease caused by the

DOSAGE AND ADMINISTRATION

Storage and Handling

Do not refreeze thawed vials.

Frozen Vials Prior to Use

Cartons of Pfizer-BioNTech COVID-19 Vaccine Multiple Dose Vials arrive in

Cartons and vials of Pfizer-BioNTech COVID-19 Vaccine with an expiry date of

Revised: 23 August 2021 2

If an ultra-low temperature freezer is not available, the thermal container in which

Transportation of Frozen Vials

If local redistribution is needed and full cartons containing vials cannot be

Thawed Vials Before Dilution

Thawed Under Refrigeration

Thawed at Room Temperature

Revised: 23 August 2021 3

Transportation of Thawed Vials

Vials After Dilution

Dosing and Schedule

The Pfizer-BioNTech COVID-19 Vaccine is administered intramuscularly as a

The FDA-approved COMIRNATY (COVID-19 Vaccine, mRNA) and the

There are no data available on the interchangeability of the Pfizer-BioNTech

A third dose of the Pfizer-BioNTech COVID-19 vaccine (0.3 mL) administered at

Revised: 23 August 2021 4

• Refer to dilution and dose preparation instructions in the panels below.

THAWING PRIOR TO DILUTION

• Before dilution invert vaccine vial

Revised: 23 August 2021 5

• Obtain sterile 0.9% Sodium Chloride

• Equalize vial pressure before removing

• Gently invert the vial containing the

Revised: 23 August 2021 6

PREPARATION OF INDIVIDUAL 0.3 mL DOSES OF PFIZER-BIONTECH

Administer the Pfizer-BioNTech COVID-19 Vaccine intramuscularly.

After dilution, vials of Pfizer-BioNTech COVID-19 Vaccine contain six doses of

Revised: 23 August 2021 7

Do not administer Pfizer-BioNTech COVID-19 Vaccine to individuals with known

Management of Acute Allergic Reactions

Appropriate medical treatment used to manage immediate allergic reactions must

Monitor Pfizer-BioNTech COVID-19 Vaccine recipients for the occurrence of

Myocarditis and Pericarditis

Postmarketing data demonstrate increased risks of myocarditis and pericarditis,

Syncope (fainting) may occur in association with administration of injectable

Revised: 23 August 2021 8

Immunocompromised persons, including individuals receiving immunosuppressant

Pfizer-BioNTech COVID-19 Vaccine may not protect all vaccine recipients.

Adverse Reactions in Clinical Trials

Adverse Reactions in Post Authorization Experience

Myocarditis and pericarditis have been reported following administration of the

Additional adverse reactions, some of which may be serious, may become

Use with Other Vaccines

There is no information on the co-administration of the Pfizer-BioNTech COVID-19

INFORMATION TO PROVIDE TO VACCINE RECIPIENTS/CAREGIVERS

As the vaccination provider, you must communicate to the recipient or their

Revised: 23 August 2021 9